Effect Of Carvedilol Versus Metoprolol On Glycemic Control In Patients With Type II Diabetes And Hypertension

This study has been completed.

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00060931

Purpose

Evaluation of the effect of two different antihypertensive treatments on control of glucose in Type II diabetic patients with high blood pressure

Condition	Intervention	Phase
Non-Insulin-Dependent Diabetes Mellitus Hypertension	Drug: carvedilol Drug: metoprolol	Phase IV

MedlinePlus related topics: Diabetes High Blood Pressure

Drug Information available for: Metoprolol Metoprolol fumarate Metoprolol succinate Metoprolol Tartrate Carvedilol

U.S. FDA Resources

Study Type:

Interventional

Study Design:

Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study

Official Title:

A Randomized, Double-Blind, Multicenter Study Comparing the Effects of Carvedilol and Metoprolol on Glycemic Control in Hypertensive Patients With Type II Diabetes Mellitus.

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Change from baseline in HbA1c at 5 months [ Time Frame: 5 months ]

Secondary Outcome Measures:

Blood pressure at 3 and 5 months Body weight at 3 and 5 months Lab levels (glucose, insulin, triglycerides, cholesterol, and albumin:creatinine ratio) at 3 and 5 months. [ Time Frame: 5 months ]

Estimated Enrollment:

1210

Study Start Date:

June 2001

Eligibility

Ages Eligible for Study:

30 Years to 80 Years

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

Criteria

Inclusion criteria:

Patients at screening must be insulin producing Type II diabetics (C peptide positive).
Patients must have a history of mild to moderate hypertension (140-179 systolic blood pressure; 90-1-9 diastolic blood pressure)
Patients must be on a stable regimen of ACE (angiotensin converting enzyme) / ARB (angiotensin receptor blocker) treatment alone or in combination with other treatments.
Patients must be on stable antidiabetic regimen (drug treated or diet alone).
Patient''s laboratory result for HbA1c must be 6.5 - 8.5 (drug treated) or 6.5 - 7.5 (diet alone).

Exclusion criteria:

Patients using beta-blocker therapy.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00060931

Show 108 Study Locations

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, M.D.

GlaxoSmithKline

More Information

Responsible Party:

GSK ( Study Director )

Study ID Numbers:

105517/347

First Received:

May 15, 2003

Last Updated:

October 15, 2008

ClinicalTrials.gov Identifier:

NCT00060931

Health Authority:

United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

Type 2 diabetes
hypertension
beta-blockers

Study placed in the following topic categories:

Metabolic Diseases
Metoprolol succinate
Diabetes Mellitus, Type 2
Vascular Diseases
Diabetes Mellitus
Endocrine System Diseases

Endocrinopathy
Metoprolol
Metabolic disorder
Glucose Metabolism Disorders
Carvedilol
Hypertension

Additional relevant MeSH terms:

Vasodilator Agents
Neurotransmitter Agents
Sympatholytics
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Adrenergic alpha-Antagonists
Cardiovascular Agents
Antihypertensive Agents

Pharmacologic Actions
Autonomic Agents
Therapeutic Uses
Adrenergic beta-Antagonists
Cardiovascular Diseases
Adrenergic Antagonists
Peripheral Nervous System Agents
Anti-Arrhythmia Agents

ClinicalTrials.gov processed this record on January 06, 2009